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(Hon) Professor Emeritus of Radiology Uppsala University, Faculty of Medicine, Sweden Physicians, researchers and radiologists in clinical practice across North America, Europe and Asia commented on the approval of the QVCAD system as an adjunct to ABUS in breast cancer screening. Due to the large number of images generated by ABUS systems, the reading time improvement of QVCAD is critical for the adoption of breast ultrasound screening. ABUS systems can generate up to 2,000 2D ultrasound images per exam compared with only 4 images for a mammography exam. The first such ABUS system, the somo.v ® Automated Breast Ultrasound System from GE/U-Systems, was approved by the FDA for breast cancer screening in 2012. The QVCAD pivotal reader study submitted in the PMA application demonstrated that QVCAD reduces reader review time significantly while preserving the accuracy of diagnosis.Ĭlinical studies have shown that ABUS can effectively detect mammography occult cancers in dense breasts. QVCAD presents the CAD results, including a C-thru™ Navigator image and CAD marks indicating regions of interest, simultaneously with the original ABUS image. Unlike existing CAD systems, which are used as a second read, QVCAD is the first FDA PMA-approved CAD system for concurrent reading. Food and Drug Administration (FDA) approval on Novemfor QVCAD, a next generation CAD system for automated breast ultrasound ("ABUS") based on deep learning algorithms. 22, 2016 /PRNewswire/ - QView Medical, Inc., the leading developer of advanced computer analysis systems for the detection of breast cancer, announced that it received U.S.